THURSDAY, May 30, 2019 (Pharmacist's Briefing) -- For patients with newly diagnosed multiple myeloma, the addition of daratumumab to lenalidomide and dexamethasone is associated with a reduced risk for disease progression or death, according to a study published in the May 30 issue of the New England Journal of Medicine.
Thierry Facon, M.D., from the University of Lille in France, and colleagues randomly assigned 737 patients with newly diagnosed multiple myeloma who were ineligible for autologous stem cell transplantation to receive daratumumab plus lenalidomide and dexamethasone (daratumumab group; 368 patients) or lenalidomide and dexamethasone alone (control group; 369 patients).
The researchers found that disease progression or death had occurred in 26.4 percent of the daratumumab group and in 38.8 percent of the control group at a median follow-up of 28.0 months. The estimated percentage of patients who were alive without disease progression at 30 months was 70.6 and 55.6 percent in the daratumumab and control groups, respectively (hazard ratio for disease progression or death, 0.56). The percentage of patients with a complete response or better was 47.6 percent in the daratumumab group and 24.9 percent in the control group. Results below the threshold for minimal residual disease were reported for 24.2 and 7.3 percent of patients in the daratumumab and control groups, respectively.
"The addition of daratumumab to lenalidomide and dexamethasone resulted in significantly longer progression-free survival, a higher response rate, an increased depth of response, and a longer duration of response than lenalidomide and dexamethasone alone," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Janssen, which manufactures daratumumab and funded the study.